In May 2023, FDA centers CDER and CBER released guidance on the integration of risk with quality management. Per FDA, these “principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.” The guidance covers the general quality risk management process but discusses the roles and responsibilities for initiating and maintaining a quality risk management process. It reiterates the main components of risk management:
- Risk assessment
- Risk control
- Risk communication
- Risk review
Further consideration is given to the manufacturer risk management methodologies and how formality in quality risk management can, and should, be scaled by risk.
Download the guidance here: 51919311fnl-Q9-R1-Quality-Risk-Management